Telephone: 087 2197421
IVDR Project Manager
Our client, a medical device company in Galway is currently looking to recruit an IVDR Project Manager for their site.
Responsibilities and Duties
- Lead a globally dispersed team to design and implement programme phase 1- assessment phase:
- IVDR EU 2017/746 awareness training and workshops
- IVDR EU 2017/746 gap analysis of the ARDx business (products and quality processes)
- Sales performance data
- Product Lifecycle Assessments leading to Product Strategies
- Work with the project teams to prepare the following project management documents, in conjunction with Project Assurance, and agree them with the Project Board:
- Project Initiation Document which include the Business Case, Project Risk & Issues Log, Project Plan (Ms Project) and Communication Strategy with Plan.
- Highlight Reports - Monthly
- Exception Report – Responsively to issues
- Business Readiness Assessment – Before implementation of a Project Output
- Maintain project progress reporting for senior stakeholders and programme leadership.
- Participate in project execution planning and senior stakeholder engagement activities.
- Manage the information flows between the directing and delivering levels of the projects.
- Participating in global regulatory leadership meetings in ARDx as required.
- Plan and facilitate project workshops.
- Establish and manage the project controls – monitoring and reporting.
- Ensure that authorization is provided in advance for project stages to ensure that progress is continual.
- Provide technical knowledge and support for the application of the new regulations across business processes either directly or through interaction with other internal and external experts.
- Organise Project Board meetings.
- The successful candidate will ideally have >3 years’ experience of IVD product development and commercialisation including CE marking. Experience of project management from inception/concept to post-implementation/sustaining using a structured approach is highly desirable.
- Experience in deploying quality and/or regulatory change programmes across a multinational/multisite organisation is desirable.
- Experience with ISO13485/2016, IVDR EU 2017/746 and/or IVD CE Marking is highly desirable.
- The job holder should be experienced with project management techniques.
- Qualification in MSP, Prince2 or PMP (Project Management Professional) certification OR equivalent evidenced experience.
- Experience of managing internationally dispersed senior stakeholders is required.
- The job holder should be proficient in the use of Project Management Tools for planning, scheduling, & task estimation.
- The job holder should have advanced Microsoft Office skills including Excel: Forms, Formulas, Functions, Pivot Tables, & Graphs, Expert in PowerPoint and MS Project
- The job holder will have the ability to organize and prioritize workflow and to meet established timeframes.
For further information on this IVDR Project Manager role in Galway please contact Anne - Marie Fox on 087 2197421 / firstname.lastname@example.org
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